Medical-device position adjusting method and medical device system

ABSTRACT

A medical device system includes a medical device that is configured to be delivered to a lesion area in a body lumen, a guide wire that is configured to guide the medical device, a port member that is configured to introduce the guide wire and the medical device into a living body, a proximal-end fixing member that is configured to fix the guide wire and the port member and is provided with an operation unit that is configured to cause the guide wire to move in an insertion/pulling-out direction from the fixed state, an anchor device provided with an anchor portion in a distal portion thereof, and an anchor-device guide wire that is configured to guide the anchor device.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Divisional of U.S. application Ser. No. 15/667,059filed on Aug. 2, 2017, and claims the benefit of Japanese ApplicationNo. JP2016-152070 filed on Aug. 2, 2016, the entire content of each ofwhich is incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a medical-device position adjustingmethod and a medical device system used in the method, in which guideand insertion into a body lumen is performed along a guide wire.

BACKGROUND

Medical treatments for a vascular lesion which use a catheter are widelyperformed because they are less surgically invasive than other vascularlesion treatments. For example, in percutaneous transluminal coronaryangioplasty, a balloon catheter is used to widen a lesion area of acoronary artery so as to improve bloodflow.

Progression of arterioscleosis results in calcification of the lesionarea and forming of a hard site. In some such lesions, a dilation forceof a balloon catheter is not sufficient to widen the calcified lesionarea. As a medical device that is capable of performing treatment evenin this case, it is known to use a scoring balloon catheter. The scoringballoon catheter has a knife-edge-shaped or linear blade provided on theballoon, and the blade produces cracks in the calcified site such thatit is easy to dilate a lumen. In addition, other known devices forremoving the calcified site or plaque include a cutter that rotates at ahigh speed, a rotary file, a transducer, and a laser cutter. One exampleof a balloon catheter provided with a blade is disclosed in U.S. Pat.No. 5,320,634.

SUMMARY

The lesion areas are not necessarily distributed in the entire region ofa blood vessel in a circumferential direction, but may be distributedonly in a part of the blood vessel in the circumferential direction. Inparticular, in a bent portion of the blood vessel, the lesion areas maybe distributed only on an outer curved side of the bent portion, or onlyon an inner curved side of the bent portion.

The medical device is inserted into the lesion area while being guidedby a guide wire that is inserted into the blood vessel in advance. Theguide wire which is inserted into the bent portion of the blood vesselhas a path that is limited, depending on, for example, a shape of thebent portion, or a state of the lesion area. In this manner, a positionof the medical device in the bent portion is also limited, and thus itis may not be possible for the medical device to appropriately approachthe lesion area. To address these and other issues, a medical-deviceposition adjusting method and a medical device system used in the methodare disclosed in which a path of a guide wire is changed in a bloodvessel after insertion thereof, thereby making it possible to adjust aposition of a medical device in the lesion area.

In an embodiment, there is provided a medical-device position adjustingmethod of adjusting a position of a medical device by adjusting a pathof a guide wire inserted into a body lumen, the method including: a stepof preparing a medical device that is delivered to a lesion area in thebody lumen, a guide wire that guides the medical device, a port memberthat introduces the guide wire and the medical device into a livingbody, a proximal-end fixing member that fixes the guide wire and theport member and is provided with an operation unit that causes the guidewire to move in an insertion/pulling-out direction from the fixed state,an anchor device provided with an anchor portion in a distal portionthereof, and an anchor-device guide wire that guides the anchor device;a step of inserting the guide wire from the port member farther forwardthan the lesion area of the body lumen; a step of inserting the anchordevice into the body lumen and fixing the guide wire to an inner wallsurface of the body lumen by the anchor portion at a position fartherforward than the lesion area; a step of inserting the medical devicefrom the port member along the guide wire into the lesion area or aposition in the vicinity of the lesion area; and a step of fixing theguide wire and the port member with the proximal-end fixing member,causing the guide wire to move in the insertion/pulling-out direction byusing the operation unit, thereby, changing a path of the guide wire inthe body lumen, and adjusting a position of the medical device in thelesion area.

In an embodiment, there is provided a medical device system including: amedical device that is delivered to a lesion area in a body lumen; aguide wire that guides the medical device; a port member that introducesthe guide wire and the medical device into a living body; a proximal-endfixing member that fixes the guide wire and the port member and isprovided with an operation unit that causes the guide wire to move in aninsertion/pulling-out direction from the fixed state, an anchor deviceprovided with an anchor portion in a distal portion thereof, and ananchor-device guide wire that guides the anchor device.

In the medical-device position adjusting method having such aconfiguration described above, it is possible to cause the guide wire tomove to a hand-side position in the body lumen, and thus it is possibleto adjust the position of the medical device to an appropriate positionin the body lumen. In other words, in the medical-device positionadjusting method, since it is possible to adjust the position of themedical device such that it is possible to exhibit the best performanceof the medical device, and it is possible to smoothly insert the medicaldevice to a desired position, it is possible to achieve improvement ofefficacy of medical treatment and shortening of time for medicaltreatment.

In addition, the lesion area may be positioned in a bent portion of thebody lumen. The guide wire may then be caused to move in theinsertion/pulling-out direction by the operation unit, and thereby thepath of the guide wire may be changed between an outer curved side andan inner curved side of the bent portion. In this manner, it is possibleto reliably adjust the position of the medical device in the bentportion of the body lumen in which it is difficult to appropriatelyposition the medical device.

In addition, in the step of inserting the medical device from the portmember along the guide wire, the medical device may be inserted to aposition in the vicinity in front of the lesion area. In the step ofadjusting the position of the medical device in the lesion area, thepath of the guide wire may be changed in the body lumen while themedical device is inserted to the position of the lesion area. In thismanner, it is possible to perform the insertion into the body lumenwhile the medical device is disposed at an appropriate position.

In addition, the anchor portion as a balloon may be dilated, and thedilation of the balloon in the body lumen may cause the guide wire to befixed to an inner wall surface of the body lumen. The method may furtherinclude a step of deflating and pulling out an anchor portion from thebody lumen, after the step of changing the path of the guide wire in thebody lumen and adjusting the position of the medical device in thelesion area. In this manner, it is possible to perform a function offixing the guide wire in a simplified structure, and it is possible toeasily collect the anchor portion from the lesion area.

In addition, the medical-device position adjusting method may furtherinclude: a step of causing the medical device to function in the lesionarea, after the step of deflating and pulling out the anchor portionfrom the body lumen. In this manner, it is possible for the anchordevice not to interfere with the function of the medical device.

In the medical device system having such a configuration describedabove, it is possible to cause the guide wire to move to a hand-sideposition in the body lumen, and thus it is possible to adjust theposition of the medical device to an appropriate position in the bodylumen. In other words, in the medical device system, since it ispossible to adjust the position of the medical device such that it ispossible to exhibit the best performance of the medical device, and itis possible to smoothly insert the medical device to a desired position,it is possible to achieve improvement of efficacy of medical treatmentand shortening of time for medical treatment.

In addition, the proximal-end fixing member may be provided with aport-member fixing portion to which the port member is fixed, aguide-wire fixing portion to which the guide wire is fixed, and amedical-device guiding portion that guides the medical device in adirection different from the insertion/pulling-out direction of theguide wire. In this manner, it is possible not to interfere with theinsertion of the medical device while the port member and the guide wireare fixed.

In addition, the guide-wire fixing portion may be provided with aholding portion that holds and fixes the guide wire, and the operationunit that causes the holding portion to move in theinsertion/pulling-out direction with respect to the port member. In thismanner, an operator can move the guide wire in the insertion/pulling-outdirection through an operation of the operation unit, and it is possibleto reliably perform fine adjustment of the movement of the guide wire.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a medical device.

FIG. 2 is a longitudinal-sectional view of a distal portion of themedical device.

FIG. 3 is a front view of an anchor device.

FIG. 4 is a front view of a proximal portion of a guiding catheter.

FIG. 5 is a front view of the proximal portion of the guiding catheterattached to a proximal-end fixing member.

FIG. 6 is a longitudinal-sectional view of the proximal-end fixingmember.

FIG. 7 is a longitudinal-sectional view of the vicinity of a lesion areaviewed in a state in which the guide wire is inserted into a bentportion of a coronary artery.

FIG. 8 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the anchor device is inserted fartherforward than the lesion area.

FIG. 9 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the anchor device is dilated.

FIG. 10 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the medical device is inserted into thelesion area and positional adjustment of a scoring balloon is performed.

FIG. 11 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the scoring balloon of the medicaldevice is dilated.

FIG. 12 is a longitudinal-sectional view of the vicinity of a lesionarea viewed in a state in which a guide wire and an anchor device areinserted farther forward than the lesion area in which a stent indwells,an anchor portion is dilated, and the medical device is inserted to thevicinity in front of the stent, in a second embodiment.

FIG. 13 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the guide wire is caused to move to aninner curved side of a bent portion and the medical device approachesthe inside of the stent.

FIG. 14 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the guide wire is caused to move to anouter curved side of the bent portion and the medical device approachesa distal portion of the stent.

FIG. 15 is a longitudinal-sectional view of the vicinity of a lesionarea viewed in a state in which a guide wire and an anchor device areinserted farther forward than the lesion area in which a stent indwells,an anchor portion is dilated, and the medical device is inserted to thevicinity in front of the stent, in a third embodiment.

FIG. 16 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which the guide wire is caused to move to anouter curved side of a bent portion and the medical device approachesthe inside of the stent.

FIG. 17 is a longitudinal-sectional view of the vicinity of the lesionarea viewed in a state in which a second stent provided in the medicaldevice is expanded after the anchor device is collected.

DETAILED DESCRIPTION

Hereinafter, embodiments of the present invention will be described withreference to the figures. Note that a dimension ratio in the figures isenlarged depending on the description and the ratio is different from anactual ratio in some cases. Note that, in this specification, a side, onwhich insertion of the medical device into a body lumen is performed, isreferred to as a “distal end” or a “distal side”, and a hand side, onwhich an operation is performed, is referred to as a “proximal end” or a“proximal side”.

A medical device system of the embodiment includes: a medical device 1that performs medical treatment on a lesion area in a blood vessel; aguide wire 5 that is used for the medical device 1; an anchor device 2that fixes a distal portion of the guide wire 5 to the inside of theblood vessel, an anchor-device guide wire 6 that is used for the anchordevice 2, a guiding catheter 3 that introduces the medical device 1 andthe anchor device 2 inside the blood vessel, and a proximal-end fixingmember 4 that fixes the guiding catheter 3 and the guide wire 5 when theposition of the guide wire 5 is changed, such that the guide wire 5 canmove in an insertion/pulling-out direction. The medical device 1 of theembodiment is used in percutaneous transluminal coronary angioplasty formedical treatment of the lesion area on a coronary artery in the heart.

First, the medical device 1 is described. The medical device 1 is ascoring balloon catheter that widens a calcified lesion area in a bloodvessel. As illustrated in FIG. 1, the medical device 1 includes acatheter shaft 10 having an elongated shape, a scoring balloon 11 thatis provided in a distal portion of the catheter shaft 10, and a hub 12that is provided in a proximal portion of the catheter shaft 10. Asillustrated in FIG. 2, the catheter shaft 10 is disposed to beconcentric with an outer tube 20 and an inner tube 21 which are formedto have elongated hollow shapes, respectively. The inner diameter of theouter tube 20 is larger than an outer diameter of the inner tube 21, andthe inner tube 21 is accommodated in an inner hollow portion of theouter tube 20. The inner hollow portion of the inner tube 21 forms aguide wire lumen 23 into which the guide wire 5 is inserted. Inaddition, a dilation lumen 22 is formed in the inner hollow portion ofthe outer tube 20, and a dilating fluid of the balloon 11 is circulatedthrough the dilation lumen on an outer side of the inner tube 21.

The guide wire 5 is inserted into the guide wire lumen 23 from anopening portion 10 a at an intermediate position of the catheter shaft10 in an axial direction. The inner tube 21 is provided only on thedistal side from the opening portion 10 a. The medical device 1 is aso-called rapid exchange type of catheter.

The inner tube 21 projects from the distal end of the outer tube 20toward the distal side. A proximal-side end portion of the balloon 11 isfixed to a distal portion of the outer tube 20, and a distal-side endportion thereof is fixed to a distal portion of the inner tube 21. Inthis manner, the inside of the balloon 11 communicates with the dilationlumen 22. The balloon 11 is dilated with the dilating fluid that isinjected therein via the dilation lumen 22. The dilating fluid may be agas or a liquid. For example, it is possible to use a gas such as heliumgas, a CO₂ gas, or O₂ gas, or a liquid such as a physiological saltsolution or a contrast agent.

It is preferable that the outer tube 20 and the inner tube 21 are madeof a material having a certain degree of flexibility. Examples of suchmaterials include polyethylene, polypropylene, polybutene,ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, anionomer, or a mixture of two or more thereof such as a polyolefin, softpolyvinyl chloride resin, polyamide, polyamide elastomer, polyester,polyester elastomer, polyurethane, fluororesin such aspolytetrafluoroethylene, silicone rubber, or latex rubber.

The scoring balloon 11 is made of a material having the flexibility,similar to the outer tube 20 or the inner tube 21. The scoring balloon11 is provided with a metal blade 13 on a front surface of the scoringballoon. The blade 13 can approach the calcified lesion area and producecracks therein during the dilation of the scoring balloon 11.

Next, the anchor device 2 will be described. As illustrated in FIG. 3,the anchor device 2 is a balloon catheter. The balloon catheter includesan anchor catheter shaft 30 having an elongated shape, an anchor portion31 as a balloon provided in a distal portion or the anchor cathetershaft 30, and an anchor catheter hub 32 provided in a proximal portionof the anchor catheter shaft 30. The anchor device 2 has the samestructure as the medical device 1 except that the anchor portion 31 is aballoon without a blade.

Next, the guiding catheter 3 will be described. As illustrated in FIG.4, the guiding catheter 3 includes a shaft 40 that is inserted into ablood vessel and a port member 41 as an insertion opening of the medicaldevice 1 or the like into the blood vessel. The shaft 40 has an innerdiameter to the extent that it is possible to insert the medical device1 and the guide wire 5 thereinto. The port member 41 is a common Yconnector and is provided with a proximal-end insertion portion 41 a ina proximal portion thereof, into which the medical device 1 or the guidewire 5 is inserted.

As illustrated in FIG. 5, the proximal-end fixing member 4 is providedwith a port-member fixing portion 50 that covers and fixes theproximal-end insertion portion 41 a of the port member 41. In addition,the proximal-end fixing member 4 is provided with a guide-wire fixingportion 51 that fixes a portion of the guide wire 5 on the proximal sidefrom the port member 41, and a medical-device guiding portion 52 intowhich a portion of the medical device 1 on the proximal side from theport member 41 is inserted.

As illustrated in FIG. 6, the port-member fixing portion 50 has an innershape that is substantially fitted in an outer shape of the proximal-endinsertion portion 41 a of the port member 41 so as to hold and fix theport member 41. The medical-device guiding portion 52 is formed to havea hollow pipe shape toward a direction different from that of aguide-wire fixing portion 51 such that a proximal portion of the medicaldevice 1 that is inserted into the port member 41 is pulled out in adirection different from that of the guide wire 5.

The guide-wire fixing portion 51 has a hollow shape and the insidethereof is provided with a holding portion 55 into which the guide wire5 is inserted and a pressing screw 56 as a screw-shaped member that isscrewed to the holding portion 55. The pressing screw 56 is brought intopressure contact with the guide wire 5 inserted into the holding portion55, by screwing of the screw and it is possible to fix the guide wire 5to the holding portion 55 in the axial direction.

The holding portion 55 is linked to the operation unit 57 that can besubjected to rotary operation. The operation unit 57 is a member havinga disk or columnar shape and a part of the operation unit is exposedoutside of the proximal-end fixing member 4. Therefore, it is possiblefor the operator who grips the proximal-end fixing member 4 to perform arotary operation of the operation unit 57. The operation unit 57 is alsolinked to a moving mechanism 58 and it is possible for the guide wire 5to move in the axial direction in response to the rotary operation. Asthe operation unit 57 moves, the holding portion 55 linked to theoperation unit 57 also moves in the axial direction of the guide wire 5.In other words, an operator performs the rotary operation of theoperation unit 57 so as to move the guide wire 5 with respect to theblood vessel in the insertion/pulling-out direction. Since the guidewire 5 moves in response to the rotary operation of the operation unit57, it is possible for the operator to perform fine adjustment such thatit is possible to easily change a path of the guide wire 5 in the bloodvessel, which will be described below.

Next, a position adjusting method of the medical device 1 in the bloodvessel will be described. First, the guiding catheter 3 is inserted intothe blood vessel from an appropriate position of an arm or the like anda distal portion of the shaft 40 is caused to approach an entrance of acoronary artery 80 while the guide wire 5 moves ahead. Then, asillustrated in FIG. 7, the guide wire 5 is caused to approach a positionfarther forward than a lesion area 81 of the coronary artery 80. In thisexample, the lesion area 81 is a calcified site on an inner wall surfaceof the coronary artery and is positioned on an outer curved side of abent portion 82 of the coronary artery 80.

Next, similar to the guide wire 5, the anchor-device guide wire 6 iscaused to approach a position farther forward than the lesion area 81 ofthe coronary artery 80. Subsequently, the anchor device 2 is insertedinto the blood vessel, as illustrated in FIG. 8, and the anchor portion31 is caused to approach a position farther forward than the lesion area81 of the coronary artery 80.

Here, as illustrated in FIG. 9, the anchor portion 31 of the anchordevice 2 is dilated. The anchor portion 31 is dilated to have the samesize as an inner diameter of the coronary artery 80 and the guide wire 5is pushed to the inner wall surface of the coronary artery 80. In thismanner, the distal portion of the guide wire 5 positioned fartherforward than the lesion area 81 is fixed to the coronary artery 80.

Next, the medical device 1 is inserted into the blood vessel from theport member 41. The medical device 1 is inserted while being guided bythe guide wire 5. The medical device 1 is inserted until the scoringballoon 11 approaches the position of the lesion area 81 of the coronaryartery 80. In the state in FIG. 9, the guide wire 5 passes an innercurved side of the bent portion 82. Therefore, as represented by adashed line in FIG. 10, the scoring balloon 11 inserted to the positionof the lesion area 81 is also positioned on the inner curved side of thebent portion 82 in the coronary artery 80.

In a case where it is not possible to effectively produce cracks in thelesion area 81 even when the scoring balloon 11 is dilated at a positionof the dashed line in FIG. 10, the proximal-end fixing member 4 isattached to the port member 41 and the guide wire 5 is fixed to theproximal-end fixing member 4, as illustrated in a change from the statein FIG. 4 to the state in FIG. 5. In this manner, the distal portion ofthe guide wire 5 is fixed to the blood vessel by the anchor portion 31,and the proximal portion thereof is fixed to the port member 41 by theproximal-end fixing member 4.

Moreover, the operator performs the rotary operation of the operationunit 57 of the proximal-end fixing member 4, thereby making it possibleto move the guide wire 5 in the insertion/pulling-out direction of theblood vessel. Since the distal portion of the guide wire 5 is fixed tothe intravascular wall surface by the anchor portion 31, the path of theguide wire 5 changes in the bent portion 82 when the guide wire 5 iscaused to move in the insertion/pulling-out direction of the bloodvessel. Specifically, when the operator causes the guide wire 5 to movein the insertion direction of the blood vessel, the guide wire 5 movesfrom the inner curved side to the outer curved side of the bent portion82 as represented by a solid line in FIG. 10. Depending on the movement,the scoring balloon 11 that is guided by the guide wire 5 also movesfrom the inner curved side to the outer curved side in the bent portion82. When the operator causes the guide wire 5 to move in the pulling-outdirection of the blood vessel, the guide wire 5 moves from the outercurved side to the inner curved side in the bent portion 82 and thescoring balloon 11 also moves from the outer curved side to the innercurved side in the bent portion 82. Until the scoring balloon 11 isappropriately positioned in the blood vessel, the positional adjustmentcontinues through the operation of the operation unit 57.

After the position of the guide wire 5 is changed by the operation unit57 and the position of the medical device 1 is adjusted to anappropriate position in the blood vessel, the scoring balloon 11 isdilated as illustrated in FIG. 11 and cracks are produced in the lesionarea 81 by the blade 13. After appropriate medical treatment isperformed on the lesion area 81, the scoring balloon 11 is deflated tobe pulled out from the blood vessel, then the anchor portion 31 isdeflated to be pulled out from the blood vessel, and the medical device1 and the anchor device 2 are collected. Further, the guide wire 5 andthe anchor-device guide wire 6 are also pulled out from the blood vesseland are collected.

In the embodiment, the medical device 1 includes the scoring balloon 11;however, another device may be included as long as the medical treatmentis performed on the calcified lesion area by using the device. Forexample, a medical device that is provided with a cutter that rotates ata high speed, a rotary file, a transducer, a laser cutter on the distalportion of the device may be used, instead of the scoring balloon 11.Also in this case, the guide wire 5 is caused to move by the operationunit 57, and thereby it is possible to appropriately adjust the positionof the medical device.

Next, a second embodiment of a position adjusting method of a medicaldevice 7 in the blood vessel will be described. In the embodiment, themedical device 7 is an image diagnosis catheter and is inserted into theblood vessel in order to diagnose a state of a stent 60 that indwells inthe lesion area 81 of the bent portion 82 of the coronary artery 80.Also in the embodiment, the guiding catheter 3 is inserted into theblood vessel and the distal portion of the shaft 40 is caused toapproach an entrance of the coronary artery 80. Then, the guide wire 5and the anchor-device guide wire 6 are caused to approach a positionfarther forward than the stent 60 that indwells in the coronary artery80 and the anchor device 2 is inserted into the blood vessel. The anchorportion 31 is dilated at the position farther forward than the stent 60and the distal portion of the guide wire 5 is fixed to the intravascularwall surface. Note that, since the anchor portion 31 is very short,there is a low possibility that the anchor portion is caught on thestent 60 during the insertion.

Since the anchor portion 31 is dilated at the position farther forwardthan the stent 60, as illustrated in FIG. 12, the distal portion of themedical device 7 is inserted to a position in the vicinity in front ofthe stent 60 in the lesion area 81. In this example, the guide wire 5moves through a position closer to the outer curved side of the bentportion 82, and there is a possibility that the distal portion of themedical device 7 will be caught on the stent 60 as is. In the hand side,the proximal-end fixing member 4 is attached to the port member 41, theguide wire 5 is fixed to the proximal-end fixing member 4, and it ispossible for the guide wire 5 to move in the insertion/pulling-outdirection by using the operation unit 57, and thereby the positionaladjustment of the medical device 7 is performed.

The guide wire 5 is caused to move in the pulling-out direction of theblood vessel by using the operation unit 57, and thereby, as illustratedin FIG. 13, the guide wire 5 moves from the outer curved side to theinner curved side in the bent portion 82 such that an insertion path ofthe medical device 7 can pass through the central portion of the bentportion 82. In this manner, it is possible for the medical device 7 notto be caught on the stent 60, and it is possible to appropriatelyperform image diagnosis. In addition, it is possible to also prevent ashift in the position of the stent 60 that occurs due to the medicaldevice 7 being caught on the stent 60.

In addition, in the state in FIG. 13, the guide wire 5 moves through aposition closer to the inner curved side of the bent portion 82 in thevicinity of the distal portion of the stent 60. Also in a state in whichthe medical device 7 is disposed in the stent 60, the guide wire 5 iscaused to move in the insertion direction of the blood vessel throughthe operation of the operation unit 57, and thereby, as illustrated inFIG. 14, the guide wire 5 moves to the outer curved side in the bentportion 82 such that the medical device 7 can pass through the centralportion of the stent 60.

As described above, while the medical device 7 is inserted to theposition of the stent 60 in the lesion area, it is possible to changethe path of the guide wire 5 in the blood vessel through the operationof the operation unit 57.

Next, a third embodiment of a position adjusting method of a medicaldevice 8 in the blood vessel will be described. In the embodiment, themedical device 8 includes, in the distal portion thereof, a balloon 71provided with a second stent 70. The stent 60 indwells in the lesionarea 81 of the bent portion 82 of the coronary artery 80 in advance. Inthe embodiment, in order to further dilate the stent 60, the secondstent 70 is delivered to the lesion area by the medical device 8, thesecond stent is dilated, and an indwelling procedure in the lesion area81 is performed.

Also in the embodiment, the guiding catheter 3 is inserted into theblood vessel and the distal portion of the shaft 40 is caused toapproach an entrance of the coronary artery 80. Subsequently, the guidewire 5 and the anchor-device guide wire 6 are caused to approach aposition farther forward than the stent 60 that indwells in the lesionarea 81 of the coronary artery 80. Next, the anchor device 2 is insertedinto the blood vessel, the anchor portion 31 is dilated at the positionfarther forward than the stent 60, and the distal portion of the guidewire 5 is fixed to the intravascular wall surface.

Since the anchor portion 31 is dilated at the position farther forwardthan the stent 60, as illustrated in FIG. 15, the distal portion of themedical device 8 is inserted to a position in the vicinity in front ofthe stent 60 in the lesion area 81. In the hand side, the proximal-endfixing member 4 is attached to the port member 41, the guide wire 5 isfixed to the proximal-end fixing member 4, it is possible for the guidewire 5 to move in the insertion/pulling-out direction of the bloodvessel by using the operation unit 57, and the positional adjustment ofthe medical device 8 is performed. In this example, since the guide wire5 moves to be closer to the inner curved side of the bent portion 82,the guide wire 5 is caused to move in the insertion direction of theblood vessel by using the operation unit 57, and the guide wire 5 movesto the outer curved side in the bent portion 82. In this manner, thepositional adjustment is performed such that the balloon 71 and thesecond stent 70 are positioned in the central portion of the stent 60.In this manner, it is possible to perform the insertion without theballoon 71 and the second stent 70 being caught on the stent 60.

In the embodiment, since the anchor device 2 and the anchor-device guidewire 6, which are inserted to the position farther forward than thelesion area, interfere with the dilation of the second stent 70, theanchor device and the anchor-device guide wire are collected before thesecond stent 70 is dilated. In other words, since the second stent 70 isdisposed in the bent portion 82, the anchor portion 31 of the anchordevice 2 is deflated and the anchor device 2 and the anchor-device guidewire 6 are pulled out from the blood vessel and are collected. Moreover,as illustrated in FIG. 17, the balloon 71 of the medical device 8 isdilated and the second stent 70 is also dilated. Since the second stent70 is dilated, the balloon 71 is deflated and the medical device 8 andthe guide wire 5 are pulled out and collected while the second stent 70indwells in the bent portion 82 as is.

As described above, for a post device for dilating the stent 60 again,the guide wire 5 is caused to move by the operation unit 57 such that itis possible to perform positional adjustment of the balloon 71 and thesecond stent 70. In the embodiment, the second stent 70 is used todilate the stent 60 again; however, the stent 60 may be dilated againwith a dilation force of the balloon 71 without using the second stent70. In this case, the anchor device 2 and the anchor-device guide wire 6may be collected before the balloon 71 is dilated or may be collectedafter the balloon 71 is dilated.

As described above, the medical-device position adjusting method ofadjusting the position of the medical device 1 by adjusting the path ofthe guide wire 5 inserted into the body lumen in the embodimentdescribed above, the method including: a step of preparing the medicaldevice 1 that is delivered to the lesion area 81 in the body lumen, theguide wire 5 that guides the medical device 1, the port member 41 thatintroduces the guide wire 5 and the medical device 1 into a living body,the proximal-end fixing member 4 that fixes the guide wire 5 and theport member 41 and is provided with the operation unit 57 that causesthe guide wire 5 to move in an insertion/pulling-out direction from thefixed state, the anchor device 2 provided with the anchor portion 31 inthe distal portion thereof, and the anchor-device guide wire 6 thatguides the anchor device 2; a step of inserting the guide wire 5 fromthe port member 41 farther forward than the lesion area 81 of the bodylumen; a step of inserting the anchor device 2 into the body lumen andfixing the guide wire 5 to the inner wall surface of the body lumen bythe anchor portion 31 at the position farther forward than the lesionarea 81; a step of inserting the medical device 1 from the port member41 along the guide wire 5 into the lesion area 81 or a position in thevicinity of the lesion area 81; and a step of fixing the guide wire 5and the port member 41 with the proximal-end fixing member 4, causingthe guide wire 5 to move in the insertion/pulling-out direction by usingthe operation unit 57, thereby, changing the path of the guide wire 5 inthe body lumen, and adjusting the position of the medical device 1 inthe lesion area 81. In this manner, it is possible to cause the guidewire 5 to move to a hand-side position in the body lumen, and thus it ispossible to adjust the position of the medical device 1 to theappropriate position in the body lumen. In other words, in themedical-device position adjusting method, since it is possible to adjustthe position of the medical device 1 such that it is possible to exhibitthe best performance of the medical device, and it is possible tosmoothly insert the medical device 1 to a desired position, it ispossible to achieve improvement of efficacy of medical treatment andshortening of time for medical treatment.

In addition, in the medical-device position adjusting method of theembodiment described above, the lesion area 81 is positioned in the bentportion 82 of the body lumen. The guide wire 5 is caused to move in theinsertion/pulling-out direction by the operation unit 57, and therebythe path of the guide wire 5 is changed between the outer curved sideand the inner curved side of the bent portion 82. In this manner, it ispossible to reliably adjust the position of the medical device 1 in thebent portion of the body lumen in which it is difficult to appropriatelyposition the medical device 1.

In addition, in the medical-device position adjusting method of theembodiment described above, in the step of inserting the medical device1 from the port member 41 along the guide wire 5, the medical device 7is inserted to the position in the vicinity in front of the lesion area81. In the step of adjusting the position of the medical device 7 in thelesion area 81, the path of the guide wire 5 is changed in the bodylumen while the medical device 7 is inserted to the position of thelesion area 81. In this manner, it is possible to perform the insertioninto the body lumen while the medical device 7 is disposed at anappropriate position.

In addition, in the medical-device position adjusting method of theembodiment described above, the anchor portion 31 as the balloon isdilated in the body lumen, and the dilation of the balloon causes theguide wire 5 to be fixed to the inner wall surface of the body lumen.The method further includes a step of deflating and pulling out theanchor portion 31 from the body lumen, after the step of changing thepath of the guide wire 5 in the body lumen and adjusting the position ofthe medical device 1 in the lesion area 81. In this manner, it ispossible to perform a function of fixing the guide wire 5 in asimplified structure, and it is possible to easily collect the anchorportion 31 from the lesion area 81.

In addition, the medical-device position adjusting method of theembodiment described above further includes a step of causing themedical device 8 to function in the lesion area, after the step ofdeflating and pulling out the anchor portion 31 from the body lumen. Inthis manner, it is possible for the anchor device 2 not to interferewith the function of the medical device 8.

In addition, the medical device system of the embodiment described aboveincludes the medical device 1 that is delivered to the lesion area 81 inthe body lumen, the guide wire 5 that guides the medical device 1, theport member 41 that introduces the guide wire 5 and the medical device 1into the living body, the proximal-end fixing member 4 that fixes theguide wire 5 and the port member 41 and is provided with the operationunit 57 that causes the guide wire 5 to move in theinsertion/pulling-out direction from the fixed state, the anchor device2 provided with the anchor portion 31 in the distal portion thereof, andthe anchor-device guide wire 6 that guides the anchor device 2.According to the medical device system, it is possible to cause theguide wire 5 to move to the hand-side position in the body lumen, andthus it is possible to adjust the position of the medical device 1 tothe appropriate position in the body lumen. In other words, in themedical device system, since it is possible to adjust the position ofthe medical device such that it is possible to exhibit the bestperformance of the medical device 1, and it is possible to smoothlyinsert the medical device 1 to the desired position, it is possible toachieve improvement of efficacy of medical treatment and shortening oftime for medical treatment.

In addition, in the medical device system of the embodiment describedabove, the proximal-end fixing member 4 is provided with the port-memberfixing portion 50 to which the port member 41 is fixed, a guide-wirefixing portion 51 to which the guide wire 5 is fixed, and themedical-device guiding portion 52 that guides the medical device 1 outin a direction different from the insertion/pulling-out direction of theguide wire 5. In this manner, it is possible not to interfere with theinsertion of the medical device 1 while the port member 41 and the guidewire 5 are fixed.

In addition, in the medical device system of the embodiment describedabove, the guide-wire fixing portion 51 is provided with a holdingportion 55 that holds and fixes the guide wire 5, and the operation unit57 that causes the holding portion 55 to move in theinsertion/pulling-out direction with respect to the port member 41. Inthis manner, the operator can cause the guide wire 5 to move in theinsertion/pulling-out direction through the operation of the operationunit 57, and it is possible to reliably perform fine adjustment of themovement of the guide wire 5.

Note that the present invention is not limited to the embodimentsdescribed above, and it is possible for those skilled in the art toperform various modifications without departing from the spirit and thescope of the invention. For example, in the embodiments described above,the medical device is used for the lesion area in the coronary artery ofthe heart; however, the medical device may be used for a lesion area ina body lumen other than the coronary artery. In addition, in theembodiments described above, the position of the guide wire is changedin the bent portion of the blood vessel; however, it is possible tochange the position of the guide wire at any position in the body lumen.In addition, types of medical devices which are subjected to thepositional adjustment are not limited to the medical devices describedabove.

What is claimed is:
 1. A medical device system comprising: a medicaldevice that is configured to be delivered to a lesion area in a bodylumen; a guide wire that is configured to guide the medical device; aport member that is configured to introduce the guide wire and themedical device into a living body; a proximal-end fixing member that isconfigured to fix the guide wire and the port member and is providedwith an operation unit that is configured to cause the guide wire tomove in an insertion/pulling-out direction from the fixed state; ananchor device provided with an anchor portion in a distal portionthereof; and an anchor-device guide wire that is configured to guide theanchor device.
 2. The medical device system according to claim 1,wherein the proximal-end fixing member is provided with a port-memberfixing portion to which the port member is fixed, a guide-wire fixingportion to which the guide wire is fixed, and a medical-device guidingportion that is configured to guide the medical device out in adirection different from the insertion/pulling-out direction of theguide wire.
 3. The medical device system according to claim 2, whereinthe guide-wire fixing portion is provided with a holding portion that isconfigured to hold and fix the guide wire, and the operation unit thatcauses the holding portion to move in the insertion/pulling-outdirection with respect to the port member.
 4. The medical device systemaccording to claim 1, wherein the anchor portion comprises a balloonthat is configured to be dilated to fix the position of a portion of theguide wire relative to the body lumen.
 5. The medical-device systemaccording to claim 1, wherein the medical device comprises a bladedballoon.
 6. A medical device system comprising: a medical device that isconfigured to be delivered to an area in a body lumen; a guide wire thatis configured to guide the medical device in the body lumen to the area;an anchor device provided with an anchor portion in a distal portionthereof; an anchor-device guide wire that is configured to guide theanchor device in the body lumen; a port member that is configured tointroduce the guide wire and the medical device into the body lumen; anda proximal-end fixing member that is configured to fix the guide wireand the port member and is provided with an operation unit that isconfigured to cause the guide wire to move in an insertion/pulling-outdirection from the fixed state, the anchor device being configured tofix an axial position of a distal portion of the guide wire relative tothe body lumen.
 7. The medical device system according to claim 6,wherein the proximal-end fixing member is provided with a port-memberfixing portion to which the port member is fixed, a guide-wire fixingportion to which the guide wire is fixed, and a medical-device guidingportion that is configured to guide the medical device out in adirection different from the insertion/pulling-out direction of theguide wire.
 8. The medical device system according to claim 7, whereinthe guide-wire fixing portion is provided with a holding portion that isconfigured to hold and fixe the guide wire, and the operation unit thatcauses the holding portion to move in the insertion/pulling-outdirection with respect to the port member.
 9. The medical device systemaccording to claim 6, wherein the anchor portion comprises a balloonthat is configured to be dilated to fix the position of a portion of theguide wire relative to the body lumen.
 10. The medical-device systemaccording to claim 6, wherein the medical device comprises a bladedballoon.